Method and device for detecting functional and metabolic data of a living organism

ABSTRACT

The invention relates to a method for detecting functional detecting functional data of a living organism, and a device for carrying out said method. The aim of the invention is to carry out a pain-free control of the corporeal values of a living organism in a simple manner, said control being able to be carried out as often as required. Ten influence of existing natural and artificial electric, electrochemical and electromagnetic fields and the changing resulting therefrom are determined. Electrodes which are used alternately as sensors and as actuators detect values and transmit the same to a downstream data detection which is embodied in an expedient manner.

[0001] The invention relates to a method for mobile or in-patientdetecting corporeal functional and metabolic data of a living organism,and a device for carrying out said method.

[0002] Many facilities are known whose measuring techniques are based ontaking blood sample from patients and indirect evaluating these samples.Use and evaluating are painful and complicated, and a special precisionin this procedure is necessary. This is a problem in active life and forelder people. Therefore, tests often are carried out in too limitedfrequencies or wrongly so that often only incomplete results areavailable for the physician in charge.

[0003] Portable measuring instruments are known, too, in particular forexample measuring instruments according to the patent specifications DE196 39 224 and 196 39 228. In these patent specifications, theconcentration of at least one substance is determined by means ofmeasuring optics and a circuitry for evaluation. Moreover, according tothe patent specification DE 32 28 551, a method for detecting the bloodsugar level is known. In this method, blood sugar is determined in thepresence of interfering substances by means of a measuring electrodewith a before connected membrane. In this case, both components form anelectrocatalytic blood sugar sensor. The measuring electrode isconnected with a potentiostat, and a reaction potential and a measuringpotential are detected. The electric current flowing during a measuringperiod is evaluated as a measuring signal. In the invention, a thirdpotential, that is more negative than the measuring potential, isimpressed to the measuring electrode after the reaction potential andbefore the measuring potential for a short time.

[0004] Moreover, a transcutaneous non-invasive method for determinationof concentration of substances in blood according to the patentspecification DE 195 18511 is known. In this invention, substances inthe blood of a patient such as lactate, glucose, cholesterin, bloodsugar, alcohol, drugs and other substances are determined in thefollowing way:

[0005] a) A signal corresponding to the amount of a substance and to theamount of water in a given body is produced by spectroscopic methods andis measured.

[0006] b) The concentration in water is detected by the ratio of thesignal value and the amount of a substance and of water.

[0007] c) From this ratio, the value of concentration of a substance inblood is calculated.

[0008] Moreover, a method and a device for polarometric determination ofsubstances in the human body according to the patent specification DE195 19 051 are known. In this invention, scattered light which escapesfrom a body region supplied with blood which is irradiated withlinear-polarized light is analyzed. From the correlation between thedetected rotational angle of polarization and the concentration of bloodsugar, the particular blood sugar level is determined.

[0009] Generally, the majority of all known solutions suffers fromdisadvantages that it is necessary to take a blood sample from thepatient and to evaluate this blood indirectly. In addition, the use ofthe customary invasive measuring methods requires an precise handlingduring an exactly defined period of time, and this is not satisfiablefor certain disabled people. An additional serious disadvantage of allknown and used devices consists in the insufficient data collection and(manual) filing by the patients. Apart from the fact that the data oftenis input insufficiently and the results are “massaged”, the “paper” isunsuited for physicians as documentation for the detailed statisticalinterpretation because of the necessary time involved and missingsoftware.

[0010] Object of the invention is to develop a method and a device whichit makes possible for patients to carry out a self-checking of theircorporeal values. This method on the living organism is painless, easyto use and practicable as often as required. Simultaneously, anindividual data collection is possible.

[0011] The object is achieved by a method and a device for mobile orin-patient detecting corporeal functional and metabolic data of a livingorganism in a non-invasive way. For this, a substance which supports theinfluencing of existing natural and artificial electric,electrochemical, and electromagnetic fields is in the organism of a testperson. According to this invention, it can be an lactate, an alcohol,cholesterin, stearin, protein, drugs, blood lipids, blood sugar, orglucose.

[0012] Electrodes are installed on the skin or nearly of the skin or areimplanted in the body surface area of the test person. These electrodesare used alternately as sensor and as actuator, register caused andreflected signals and save these signals. The saved signals are input ina following computer system. Then sum values are calculated from thedetected values on the basis of the course of time. These sum values areassigned to reference values and displayed regularly together with thesereference values for comparison purposes. The data can be displayed on ascreen but also on a writer. Both devices can be connected with aprinter for data output of the detected values. The detected andbalanced values can also be input in a data storage system forcomparison, for further disposal and for recalling them if required.

[0013] The signal for assessment of the test person can be obtainedcontinuously or discontinuously.

[0014] The available natural and artificial electric, electrochemicaland electromagnetic values are physical parameters. A relevant physicalparameter can be the field strength. It is also possible to register thedensity of field lines, a potential difference, an amperage, a voltage,or at least two quantities in combination. For storage and documentationpurposes, the body temperature, the skin resistance, and the gasexchange through the skin per unit of time are relevant.

[0015] Referring to specific relevant body regions of the test person,it is possible to influence relevant skin areas as a whole or partiallyand concentrated. The data collection is possible point-like, in theform of a line, or in the form of an area. It is also possible to adaptthe arrangement to the relevant skin areas, for example in the form of amatrix. It is also possible to implant at least one electrode in thebody of the test person. An arrangement of the electrodes outside of thetest person is disregarded here.

[0016] A device according to this invention, first, comprises ofelectrodes which can be used as sensors or as actuators. Theseelectrodes are arranged with reference to the skin surface of the testperson and are electrically/electronically connected with an analogchangeover facility which is arranged before an operational amplifierstage. The operational amplifier stage consists of an impedanceconverter preamplifier with filter. An analog-digital converter with adigital signal processor is arranged after the operational amplifierstage which is for conditioning. This processor is connected to acomputer stage which processes and stores the normalized and digitizedmeasuring values. Therefore, the computer stage can preferably have anintegrated storage module.

[0017] When the individual components of the device according to thisinvention are arranged separately, it can designed so that the data istransmitted wireless. But it is also possible to equip the individualcomponents with an optical communication interface for transmitting thedata.

[0018] The operational amplifier stage is adapted to the physicalproperties of the electrodes. A preferential version according to thisinvention intends to equip the analog-digital converter with the signalprocessor scalably according to the number of the used primary contacts.Preferably, the computer stage can be designed also scalably.

[0019] A further preferential version according to the invention intendsthat the computer stage controls the generator for adaptive stimulationand with this the changeover between sensor and actuator operation.

[0020] Preferably, a display is arranged after the computer stage inorder to can interpret the obtained diagrams. It is also possible toequip the computer stage with a deposit regulator, which is locatedafter the computer stage and controls this unit.

[0021] To eliminate detected interferences, the operational amplifierstage is equipped with an adaptive filter element

[0022] At least individual components can be implanted in the livingorganism. When the whole unit is sufficiently miniaturized it is alsopossible to arrange it in the living organism.

[0023] Starting point for the development of the method and for the useaccording to the invention was that there is a natural human field whichcan be established in the living organism. I was also established thatthe influence of substances in blood, which can be correlated, ismeasurable as abnormality in the natural human field. This makes itpossible to use advantageously the method and the device according tothe invention in a complete non-invasive way.

[0024] Therefore, it is possible to simplify considerably the continuouschecking of corporeal values of a living organism by means of anon-invasive method. It is also possible to adjust continuously andstably corporeal values during a medical treatment.

[0025] It is also possible to obtain body values for the assessment ofmetabolic phenomena such as change of blood substances, blood alcohol,glucose. muscle efficiency, skin resistance, cutaneous circulation, painlocation and other values of that kind from a seemingly healthyorganism.

[0026] All data can be stored, analyzed and visualized separately foreach person, can be displayed as individual daily profiles, weeklyprofiles and/or any other time profiles of physical data and theirconsequences such as concentration of substances and so on, and can betelecommunicated in other data systems.

[0027] It is a disadvantage of customary methods that they arecomplicated because of use of a lot of paper, when established data arecollected, and mistakes, which are connected with that. Thisdisadvantage is eliminated by the computer-aided data collection and thepossibility, the established data to transfer to a specialist forfurther medical treatment or something like that.

[0028] In the following, the invention is described on the basis of anembodiment, in which the method as well as the device are explained indetail.

[0029] In the accompanying drawings show

[0030]FIG. 1 the basic principle of course of measurement in case of useof the method according to the invention,

[0031]FIG. 2 a presentation of preferred sensor positions on a humanorganism, and

[0032]FIG. 3 a principle circuitry of a device equipped according to theinvention.

[0033] A number of 1 . . . n electrodes 1 is fixed onto the body surfaceof a test person. All well-tolerated precious metals (gold, silver,platinum) or also conductive plastics or ceramics can be used asconductive material. All insulating substances such plastics or textilescan be used as carrier for the electrodes. In the embodiment, 6electrodes are used which are miniaturized and embedded in conductiverubber. The rubber is enclosed for its fixture in a flexible polymer sothat it adapts to the body of the test person.

[0034] The electronic system is also arranged on the carrier. Thecarrier is also intended to fix it on the body of the test person.

[0035] The electrodes 1 are designed so that they can act as sensor aswell as actuator.

[0036] The component after the electrodes is the signal conditioning(A). In this component, an arrangement exists consisting of the singlechannel analog switch 2, the impedance converter preamplifier 3 and thefilter 4. The latter form together the operational amplifier stage asunit.

[0037] If the electrodes 1 are used as sensor, the sensor signal isinput in the impedance converter preamplifier 3. The after connectedfilter 4 achieves two objects. First, it is supposed to suppressinterferences caused by induced fields in the environment and, second,it is supposed to limit the signal that is to transfer for dataconverting. In the embodiment, the filter 4 is designed multistageactively. The filter parameters are adapted and adjusted by means of thedigital signal processor 5 and the processor 6. In this way, an analogsignal is available that is suitable for processing.

[0038] If the electrodes are used as actuator, they are linked to thegenerator 7 by means of the single channel analog switch 2.

[0039] The data converting is carried out in the component C. In thiscomponent, a scalable interface is integrated in the data convertingstage 8 which is linked to the signal processor 5 so that it is possibleto operate several electrodes. Thus the electrodes 1 can be used assingle elements or as matrix on the data converting stage 8. Theselecting is achieved by the processor 6.

[0040] A high-resolution rapid analog-digital converter 8 is afterconnected to the scalable interface. This converter is provided with asignal processor interface. The analog-digital converter 8 is selectedby the signal processor 5 and serves as data source for the signalprocessor 5. In the signal processor 5, the arriving data stream ispreprocessed by detecting and eliminating the interferences. Moreover,the parameters for the adaptive filter are determined.

[0041] All raw data is transferred via a bus system, and the processor 6controls the signal processor 5 via a control bus.

[0042] The generator 7 in this component is also controlled via this bussystem (data bus and control bus). Several stored signal courses.Further parameters for the generator 7 are intensity and frequency. Ifnew signal courses are synthesized, these can be stored specifically foreach user.

[0043] The component D is the so-called controller segment. It serves ascentral control instance in the system. It observes all systemfunctions, generates cyclically self-tests and carries out the onlinecalibration of the whole system. It can also observe comparisonmeasurements using classical analytical methods.

[0044] The components communication module 9, storage unit 12, systemdisplay 10, and keyboard 11 are connected with the controller via thebus system. The communication module 9 is designed in modular technique,and therefore it can be adapted to different transmission channels. Itis also possible to implement software or hardware protocols.

[0045] The storage unit 12 is intended for long-term storage of theobtained data and for temporary intermediate storage of the currentdata. These storage unit 12 is preferably subdivided into a storage,which is implemented in the system as an integral part, and a extendableexternal storage.

[0046] A further external storage device can be equipped withinterchangeable storage devices.

[0047] A specific evaluation program carries out the analysis of themeasuring data for each person separately and program steps such as acorrelation which, for example, reference data for these people,historical values and values like that, and deviations of time valuesand values like that. Moreover, the evaluation program carries outcalculations such as calculations for determining the concentration ofparticular chemical substances.

[0048] Reference Signs

[0049] Electrodes 1

[0050] Single channel analog switch 2

[0051] Impedance converter preamplifier 3

[0052] Filter 4

[0053] Signal processor 5

[0054] Processor 6

[0055] Generator 7

[0056] Analog-digital converter 8

[0057] Communication module 9

[0058] System display 10

[0059] Keyboard 11

[0060] Storage unit 12

1. Method for mobile or in-patient detecting corporeal functional andmetabolic data of a living organism characterized by the fact that thereis a substance in a test person which supports the influencing ofexisting natural and artificial electric, electrochemical, andelectromagnetic fields in the organism of these test person, that thechange of natural and artificial electric, electrochemical, andelectromagnetic fields as physical parameters is detected by electrodeswhich alternately are used as sensor and as actuator and are related tothe skin surface of a test person, that the detected signals areregistered and stored, that the stored signals are input in dataprocessing equipment, that sum values are formed from the determinedsignals on the basis of their course of time, and that these sum valuesare provided for the computer-aided determination and evaluation of asubstance which supports the influencing of existing natural electric,electrochemical, and electromagnetic fields.
 2. Method according toclaim 1 characterized by the fact that the collection of change of thenatural and artificial electric, electrochemical, and electromagneticfields is carried out continuously.
 3. Method according to claim 1characterized by the fact that the collection of change of the naturaland not natural electric, electrochemical, and electromagnetic fields iscarried out discontinuously.
 4. Method according to one of the claims 1to 3 characterized by the fact that the effect of the electrodes, whichcan be used as sensor and as actuator, on relevant skin areas occurspartially.
 5. Method according to one of the claims 1 to 3 characterizedby the fact that the effect of the electrodes, which can be used assensor and as actuator, on relevant skin areas occurs globally. 6.Method according to one of the claims 1 to 5 characterized by the factthat the detecting the change of natural and artificial electric,electrochemical, and electromagnetic fields occurs point-like.
 7. Methodaccording to one of the claims 1 to 5 characterized by the fact that thedetecting the change of natural and artificial electric,electrochemical, and electromagnetic fields occurs in the form of aline.
 8. Method according to one of the claims 1 to 5 characterized bythe fact that the detecting the change of natural and artificialelectric, electrochemical, and electromagnetic fields occurs in the formof an area.
 9. Method according to one of the claims 1 to 8characterized by the fact that the considered physical parameter is thefield strength.
 10. Method according to one of the claims 1 to 9characterized by the fact that the considered physical parameter is thedensity of field lines.
 11. Method according to one of the claims 1 to10 characterized by the fact that the considered physical parameter is apotential difference.
 12. Method according to one of the claims 1 to 11characterized by the fact that the considered physical parameter is theamperage.
 13. Method according to one of the claims 1 to 12characterized by the fact that the considered physical parameter is theelectric voltage.
 14. Method according to one of the claims 1 to 13characterized by the fact that the detected signals are provided fordiagrams.
 15. Method according to one of the claims 1 to 14characterized by the fact that parallel reflected signals are detectedadequately to the body temperature.
 16. Method according to one of theclaims 1 to 15 characterized by the fact that parallel reflected signalsare detected adequately to the skin resistance.
 17. Method according toone of the claims 1 to 16 characterized by the fact that parallelreflected signals are detected adequately to gas exchange through theskin per time unit.
 18. Method according to one of the claims 1 to 17characterized by the fact that the substance which supports theinfluencing of existing natural and artificial electric,electrochemical, and electromagnetic fields is lactate.
 19. Methodaccording to one of the claims 1 to 17 characterized by the fact thatthe substance which supports the influencing of existing natural andartificial electric, electrochemical, and electromagnetic fields isalcohol.
 20. Method according to one of the claims 1 to 17 characterizedby the fact that the substance which supports the influencing ofexisting natural and artificial electric, electrochemical, andelectromagnetic fields is cholesterin.
 21. Method according to one ofthe claims 1 to 17 characterized by the fact that the substance whichsupports the influencing of existing natural and artificial electric,electrochemical, and electromagnetic fields is stearin.
 22. Methodaccording to one of the claims 1 to 17 characterized by the fact thatthe substance which supports the influencing of existing natural andartificial electric, electrochemical, and electromagnetic fields isprotein.
 23. Method according to one of the claims 1 to 17 characterizedby the fact that the substance which supports the influencing ofexisting natural and artificial electric, electrochemical, andelectromagnetic fields are drugs.
 24. Method according to one of theclaims 1 to 17 characterized by the fact that the substance whichsupports the influencing of existing natural and artificial electric,electrochemical, and electromagnetic fields are blood lipids.
 25. Methodaccording to one of the claims 1 to 17 characterized by the fact thatthe substance which supports the influencing of existing natural andartificial electric, electrochemical, and electromagnetic fields isglucose.
 26. Method according to one of the claims 1 to 17 characterizedby the fact that the substance which supports the influencing ofexisting natural and artificial electric, electrochemical, andelectromagnetic fields is blood sugar.
 27. Device for realization of themethod according to one of the claims 1 to 26 characterized by the factthat electrodes (1) are arranged which are related to the skin surfaceof a test person and can be used as sensor and as actuator and which areelectrically/electronically connected with an analog changeover facility(2) arranged before an operational amplifier stage (3, 4), which furtherare connected with the impedance preamplifier (3) for conditioning andan analog-digital converter (8) with an after connected digital signalprocessor (5), and that this processor is connected with a computersystem stage for processing of the normalized and digitized measuringvalues.
 28. Device according to claim 27, characterized by the fact thatindividual components are arranged separately.
 29. Device according toclaim 27 or claim 28 characterized by the fact that the components arearranged separately are designed in that way that the data istransmitted wireless.
 30. Device according to one of the claims 27 to 29characterized by the fact that the components are designed in that waythat they transmit the data via an optical communication interface. 31.Device according to one of the claims 27 to 30 characterized by the factthat the electrodes (1), which can be used as sensor and as actuator,are arranged in groups.
 32. Device according to one of the claims 27 to31 characterized by the fact that the electrodes (1), which can be usedas sensor and as actuator, are arranged in groups in a matrix. 33.Device according to one of the claims 27 to 32 characterized by the factthat at least individual components of the system are implanted in thebody of a test person.
 34. Device according to one of the claims 27 to33 characterized by the fact that the operational amplifier stage isadapted to the physical properties of the electrodes.
 35. Deviceaccording to one of the claims 27 to 34 characterized by the fact thatthe analog-digital converter (8) with the digital signal processor (5)is designed scalably according to the number of the used primarycontacts.
 36. Device according to one of the claims 27 to 35characterized by the fact that the computer system stage is designedscalably.
 37. Device according to one of the claims 27 to 36characterized by the fact that the computer system stage is designed inthat way that it controls the generator (7) for the adaptive stimulationand with this the changeover between sensor and actuator operation. 38.Device according to one of the claims 27 to 37 characterized by the factthat a display (10) is arranged after the computer system stage. 39.Device according to one of the claims 27 to 38 characterized by the factthat the computer system stage has an integrated storage unit (12). 40.Device according to one of the claims 27 to 39 characterized by the factthat the operational amplifier stage (3; 4) has an adaptive filterelement (4) for the elimination of recognized interferences.
 41. Deviceaccording to claim 40 characterized by the fact that the adaptive filterelement (4) is designed as a multistage type.
 42. Device according toone of the claims 27 to 41 characterized by the fact that the computersystem stage is connected with a depot regulator and controls it. 43.Device according to claim 42 characterized by the fact that the depotregulator is arranged within the living organism.
 44. Device accordingto claim 42 characterized by the fact that the depot regulator isarranged outside the living organism.